# K993741: EZ LDL Cholesterol Test System

- Pathway: 510(k) (Traditional)
- Applicant: Sigma Diagnostics, Inc.
- Decided: Jul 3, 2000 after 242 days
- Product code: MRR (System, Test, Low Density, Lipoprotein)
- Device class: 1
- Regulation: 21 CFR 862.1475
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K982271 (1998). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982271: Wako Direct LDL-C, Wako Chemicals USA, Inc. (1998) Summary page 1.

## Indications for use
The Sigma Diagnostics EZ™ LDL- cholesterol test system is a device intended to measure LDL-cholesterol in plasma and serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.

Source page: https://510kreport.com/device/K993741
Methodology: https://510kreport.com/methodology